Amgen reports investigational therapy Denosumab increases bone mineral density

By Elaine Rigoli

Tampa, Fla., Feb. 22 - Amgen announced Wednesday the publication of phase 2 data demonstrating twice-yearly injections of denosumab (previously referred to as AMG 162), a RANK Ligand inhibitor, significantly increased bone mineral density (BMD) in the total hip, lumbar spine, distal 1/3 radius and total body compared to a placebo.

The results of this one-year study appeared in the Feb. 23 issue of the New England Journal of Medicine. Data results also included an open-label Fosamax (alendronate)(a) arm of the same clinical trial.

Researchers reported that subcutaneous injections of denosumab significantly increased bone mineral density at the total hip to 3.6% from 1.9% in women who were administered the therapy twice yearly as compared with a decrease of 0.6% in the placebo group at one year.

The open label Fosamax group receiving 70 mg weekly had an increase of 2.1% during the same timeframe. Results also indicated that denosumab had a rapid onset of action. A significant decrease in serum levels of C-telopeptide, a biomarker of bone resorption, was achieved within 72 hours after dosing, the release said.

Denosumab targets RANK Ligand, a protein that acts as the primary mediator of osteoclast (cells that break down bone) activity. This investigational therapy is the first RANK Ligand inhibitor in late-stage development, the release said.

Amgen is studying denosumab for its potential in a broad range of conditions associated with bone destruction including osteoporosis, treatment-induced bone loss, bone metastases, multiple myeloma and rheumatoid arthritis.

In the one-year trial results, researchers also reported twice-yearly subcutaneous injections of denosumab significantly increased lumbar spine bone mineral density to 6.7% from 3.0% after 12 months as compared with a decrease of 0.8% in the placebo-treated patients.

Across all doses and dosing intervals, distal 1/3 radius bone mineral density increased to 1.3% from 0.4% as compared with a decrease of 2.0% in those taking a placebo, and total-body bone mineral density increased to 2.8% from 0.6% as compared with a decrease of 0.2% in the placebo group.

The incidence of adverse events was similar among the denosumab, placebo and Fosamax groups, with the exception of dyspepsia. Dyspepsia occurred in 7% of placebo patients, 6% to 15% of denosumab patients and 26% of open-label Fosamax patients.

Of the 10 million Americans estimated to have osteoporosis, 8 million are women and 2 million are men. In addition, one in two women and one in four men over age 50 will have an osteoporosis-related fracture in their remaining lifetime.

In Europe, recent estimates have stated that about 3.8 million people have experienced bone fractures related to osteoporosis.

Amgen discovers, develops and delivers innovative human therapeutics. The company is based in Thousand Oaks, Calif.

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